HRP20211140T1 - Pripravci protiv raka - Google Patents
Pripravci protiv raka Download PDFInfo
- Publication number
- HRP20211140T1 HRP20211140T1 HRP20211140TT HRP20211140T HRP20211140T1 HR P20211140 T1 HRP20211140 T1 HR P20211140T1 HR P20211140T T HRP20211140T T HR P20211140TT HR P20211140 T HRP20211140 T HR P20211140T HR P20211140 T1 HRP20211140 T1 HR P20211140T1
- Authority
- HR
- Croatia
- Prior art keywords
- solid dispersion
- formulation
- hpmcas
- poly
- meth
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 15
- 230000001093 anti-cancer Effects 0.000 title 1
- 239000007962 solid dispersion Substances 0.000 claims 25
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims 12
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 claims 11
- 238000009472 formulation Methods 0.000 claims 11
- 229920000193 polymethacrylate Polymers 0.000 claims 10
- HJBWBFZLDZWPHF-UHFFFAOYSA-N apalutamide Chemical compound C1=C(F)C(C(=O)NC)=CC=C1N1C2(CCC2)C(=O)N(C=2C=C(C(C#N)=NC=2)C(F)(F)F)C1=S HJBWBFZLDZWPHF-UHFFFAOYSA-N 0.000 claims 9
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- 239000002246 antineoplastic agent Substances 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 239000002245 particle Substances 0.000 claims 3
- 239000006185 dispersion Substances 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 238000001694 spray drying Methods 0.000 claims 2
- 206010060862 Prostate cancer Diseases 0.000 claims 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 229960004103 abiraterone acetate Drugs 0.000 claims 1
- UVIQSJCZCSLXRZ-UBUQANBQSA-N abiraterone acetate Chemical group C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CC[C@@H](CC4=CC[C@H]31)OC(=O)C)C=C2C1=CC=CN=C1 UVIQSJCZCSLXRZ-UBUQANBQSA-N 0.000 claims 1
- 239000003098 androgen Substances 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 238000009474 hot melt extrusion Methods 0.000 claims 1
- 239000003112 inhibitor Substances 0.000 claims 1
- 125000005395 methacrylic acid group Chemical group 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims 1
- 229960004618 prednisone Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000006104 solid solution Substances 0.000 claims 1
- 239000007916 tablet composition Substances 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Oncology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Processes Of Treating Macromolecular Substances (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (33)
1. Čvrsta disperzija koja sadrži
[image]
poli(met)akrilatni kopolimer i hidroksipropil metil celuloza acetat sukcinat (HPMCAS).
2. Čvrsta disperzija prema patentnom zahtjevu 1 što se disperzija sastoji od ARN-509, poli(met)akrilatnog kopolimera i HPMCAS.
3. Čvrsta disperzija prema patentnom zahtjevu 1 ili 2 naznačena time što je težinski omjer ARN-509 : (poli(met)akrilatni kopolimer i HPMCAS) u čvrstoj disperziji u rasponu od 1 : 1 do 1 : 5.
4. Čvrsta disperzija prema patentnom zahtjevu 3 naznačena time što težinski omjer ARN-509 : (poli(met)akrilatni kopolimer i HPMCAS) u čvrstoj disperziji iznosi 1:3.
5. Čvrsta disperzija prema patentnom zahtjevu 3 naznačena time što težinski omjer ARN-509 : (poli(met)akrilatni kopolimer i HPMCAS) u čvrstoj disperziji iznosi 1:2.
6. Čvrsta disperzija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time što se težinski omjer poli(met)akrilatni kopolimera prema HPMCAS u čvrstoj disperziji kreće u rasponu od 5:95 do 95:5.
7. Čvrsta disperzija prema patentnom zahtjevu 6 naznačena time što se težinski omjer poli(met)akrilatnog kopolimera prema HPMCAS u čvrstoj disperziji kreće u rasponu od 25:75 do 75:25.
8. Čvrsta disperzija prema patentnom zahtjevu 7 naznačena time što je težinski omjer poli(met)akrilatnog kopolimera prema HPMCAS u čvrstoj disperziji 50:50.
9. Čvrsta disperzija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time što je ARN-509 prisutan u amorfnom obliku.
10. Čvrsta disperzija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time što je disperzija čvrsta otopina.
11. Čvrsta disperzija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time što je poli(met)akrilatni kopolimer poli(metakrilna kiselina-ko-etil akrilat) 1:1.
12. Čvrsta disperzija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time što HPMCAS je HPMCAS LG (granulirani razred).
13. Čvrsta disperzija prema bilo kojem od prethodnih patentnih zahtjeva naznačena time što se može dobiti sušenjem raspršivanjem.
14. Čvrsta disperzija prema bilo kojem od patentnih zahtjeva 1 do 12 naznačena time što se može dobiti ekstruzijom vruće taljevine.
15. Čestica naznačena time što se sastoji od čvrste disperzije kako je definirana u bilo kojem od prethodnih patentnih zahtjeva.
16. Čestica naznačena time što sadrži čvrstu disperziju kako je definirana u bilo kojem od patentnih zahtjeva 1 do 14.
17. Farmaceutska formulacija naznačena time što sadrži farmaceutski prihvatljiv nosač i čvrstu disperziju prema bilo kojem od zahtjeva 1 do 14.
18. Farmaceutska formulacija naznačena time što sadrži farmaceutski prihvatljiv nosač i česticu prema patentnom zahtjevu 15 ili 16.
19. Formulacija prema patentnom zahtjevu 17 ili 18 naznačena time što formulacija sadrži 60 mg ARN-509.
20. Formulacija prema patentnom zahtjevu 17 ili 18 naznačena time što formulacija sadrži 120 mg ARN-509.
21. Formulacija prema patentnom zahtjevu 17 ili 18 naznačena time što formulacija sadrži 240 mg ARN-509.
22. Formulacija prema bilo kojem od patentnih zahtjeva 17 do 21 naznačena time što se težina čvrste disperzije kreće u rasponu od 20 do 40% ukupne težine formulacije.
23. Formulacija prema bilo kojem od patentnih zahtjeva 17 do 22 naznačena time što je formulacija tableta.
24. Formulacija prema patentnom zahtjevu 23 naznačena time što je pogodna za oralnu primjenu.
25. Postupak za pripremu čvrste disperzije prema patentnom zahtjevu 13 naznačen time što obuhvaća korake miješanja ARN-509, poli(met)akrilatnog kopolimera i HPMCAS u prikladnom otapalu i sušenje raspršivanjem navedene smjese.
26. Postupak prema patentnom zahtjevu 25 naznačen time što je prikladno otapalo smjesa diklormetana i metanola.
27. Postupak prema patentnom zahtjevu 26 naznačen time što težinski omjer diklormetana prema metanolu u smjesi iznosi 50:50.
28. Farmaceutska formulacija prema bilo kojem od patentnih zahtjeva 17 do 24 naznačena time što je namijenjena upotrebi u liječenju raka prostate.
29. Farmaceutska formulacija za upotrebu prema patentnom zahtjevu 28 naznačena time što je formulacija za oralnu primjenu.
30. Kombinacija farmaceutske formulacije prema bilo kojem od patentnih zahtjeva 17 do 24 i drugog sredstva protiv raka.
31. Kombinacija prema patentnom zahtjevu 30 naznačena time što je drugo sredstvo protiv raka inhibitor biosinteze androgena.
32. Kombinacija prema patentnom zahtjevu 30 naznačena time što je drugo sredstvo protiv raka abirateron acetat.
33. Kombinacija prema bilo kojem od patentnih zahtjeva 30 do 32 naznačena time što nadalje sadrži prednizon.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14196605 | 2014-12-05 | ||
| PCT/US2015/063671 WO2016090105A1 (en) | 2014-12-05 | 2015-12-03 | Anticancer compositions |
| EP15820351.3A EP3226843B1 (en) | 2014-12-05 | 2015-12-03 | Anticancer compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20211140T1 true HRP20211140T1 (hr) | 2021-10-15 |
Family
ID=52006907
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20211140TT HRP20211140T1 (hr) | 2014-12-05 | 2021-07-19 | Pripravci protiv raka |
Country Status (33)
| Country | Link |
|---|---|
| US (3) | US10285948B2 (hr) |
| EP (2) | EP3226843B1 (hr) |
| JP (1) | JP6830892B2 (hr) |
| KR (1) | KR102387089B1 (hr) |
| CN (1) | CN106999432A (hr) |
| AR (1) | AR102925A1 (hr) |
| AU (1) | AU2015358497B2 (hr) |
| CA (1) | CA2969675C (hr) |
| CL (1) | CL2017001373A1 (hr) |
| CO (1) | CO2017005574A2 (hr) |
| CR (1) | CR20170218A (hr) |
| CY (1) | CY1124504T1 (hr) |
| DK (1) | DK3226843T3 (hr) |
| EA (1) | EA201791251A1 (hr) |
| ES (1) | ES2883187T3 (hr) |
| HR (1) | HRP20211140T1 (hr) |
| HU (1) | HUE054935T2 (hr) |
| IL (1) | IL252325A0 (hr) |
| LT (1) | LT3226843T (hr) |
| MA (1) | MA41111B1 (hr) |
| MD (1) | MD3226843T2 (hr) |
| MX (1) | MX2017007206A (hr) |
| MY (1) | MY192931A (hr) |
| NI (1) | NI201700068A (hr) |
| PH (1) | PH12017500979A1 (hr) |
| PL (1) | PL3226843T3 (hr) |
| PT (1) | PT3226843T (hr) |
| RS (1) | RS62421B1 (hr) |
| SG (1) | SG11201704386VA (hr) |
| SI (1) | SI3226843T1 (hr) |
| TW (1) | TWI709403B (hr) |
| UA (1) | UA123538C2 (hr) |
| WO (1) | WO2016090105A1 (hr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI3305285T1 (sl) | 2012-09-26 | 2021-03-31 | Aragon Pharmaceuticals, Inc. | Anti-androgeni za zdravljenje proti kastraciji odpornega ne-metastatskega raka |
| EP3226843B1 (en) | 2014-12-05 | 2021-05-26 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| JOP20200076A1 (ar) | 2017-10-16 | 2020-04-30 | Aragon Pharmaceuticals Inc | مضادات أندروجين لعلاج سرطان البروستاتا غير النقيلي المقاوم للاستئصال |
| WO2020144647A1 (en) | 2019-01-10 | 2020-07-16 | Aragon Pharmaceuticals, Inc. | Pharmaceutical composition comprising apalutamide dispersed in apple sauce |
| AU2020215177A1 (en) | 2019-01-30 | 2021-08-12 | Janssen Pharmaceutica Nv | Methods of treating prostate cancer based on molecular subtypes |
| AU2020215176A1 (en) | 2019-01-30 | 2021-08-05 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer |
| WO2020239478A1 (en) | 2019-05-28 | 2020-12-03 | Pharma Mar, S.A. | Trabectedin for treating sarcomas based on genomic markers |
| EP4054572A1 (en) | 2019-11-04 | 2022-09-14 | Aragon Pharmaceuticals, Inc. | Androgen receptor inhibitors for the treatment of non-metastatic castration-resistant prostate cancer in subjects with severe hepatic impairment |
| WO2021245285A1 (en) | 2020-06-05 | 2021-12-09 | Janssen Pharmaceutica Nv | Methods of treating prostate cancer based on molecular subtypes |
| TW202228794A (zh) | 2020-09-04 | 2022-08-01 | 美商艾瑞岡醫藥公司 | 用於治療前列腺癌之方法 |
| WO2022195407A1 (en) | 2021-03-19 | 2022-09-22 | Aragon Pharmaceuticals, Inc. | Methods for treating prostate cancer |
| WO2023152611A1 (en) | 2022-02-11 | 2023-08-17 | Aragon Pharmaceuticals, Inc. | Apalutamide and relugolix for the treatment of prostate cancer |
| WO2023209555A1 (en) | 2022-04-26 | 2023-11-02 | Aragon Pharmaceuticals, Inc. | Approved drug products and methods for treating prostate cancer |
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| JP2742331B2 (ja) | 1992-03-31 | 1998-04-22 | ブリテイツシユ・テクノロジー・グループ・リミテツド | 癌治療に有用な１７位置換ステロイド |
| ES2287971T3 (es) | 1997-08-11 | 2007-12-16 | Pfizer Products Inc. | Dispersiones farmaceuticas solidas con biodisponibilidad incrementada. |
| AU2001232348A1 (en) | 2000-02-21 | 2001-08-27 | Takeda Chemical Industries Ltd. | Sustained release preparations of physiologically active compound hardly solublein water and production process and use of the same |
| DE60206889T2 (de) | 2001-02-27 | 2006-07-27 | Astrazeneca Ab | Pharmazeutische formulierung enthaltend bicalutamid |
| EE200300476A (et) | 2001-04-02 | 2003-12-15 | Astrazeneca Ab | 4-tsüanotrifluoro-3-(4-fluorofenüülsulfonüül)-2-hüdroksü-2-metüülpropiono-m-toluidii di ja PVP-d sisaldav tahke farmatseutiline kompositsioon |
| BR0210530A (pt) | 2001-06-22 | 2004-06-22 | Pfizer Prod Inc | Composições farmacêuticas de drogas e poìimeros acìdicos neutralizados |
| SE0103424D0 (sv) | 2001-10-15 | 2001-10-15 | Astrazeneca Ab | Pharmaceutical formulation |
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| PT2656841T (pt) | 2006-03-27 | 2016-09-28 | Univ California | Modulador do recetor de androgénios para o tratamento de cancro da próstata e doenças associadas ao recetor de androgénios |
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| PL3348553T3 (pl) * | 2012-06-07 | 2021-02-08 | Aragon Pharmaceuticals, Inc. | Postacie krystaliczne modulatora receptora androgenowego |
| US10668156B2 (en) | 2012-06-22 | 2020-06-02 | Basf Se | Active-ingredient-containing solid dispersions based on diethylaminoethyl methacrylate copolymers |
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| KR102121404B1 (ko) | 2013-03-15 | 2020-06-11 | 썬 파마 글로벌 에프제트이 | 아비라테론 아세테이트 제제 |
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| CN105636594A (zh) | 2013-08-12 | 2016-06-01 | 托凯药业股份有限公司 | 使用雄激素靶向疗法用于治疗肿瘤性疾病的生物标记物 |
| US9566280B2 (en) * | 2014-01-28 | 2017-02-14 | Massachusetts Institute Of Technology | Combination therapies and methods of use thereof for treating cancer |
| CA2940984A1 (en) | 2014-02-05 | 2015-08-13 | Lek Pharmaceuticals D.D. | Solid pharmaceutical compositions of androgen receptor antagonists |
| DK3102595T3 (en) | 2014-02-06 | 2019-02-04 | Hoffmann La Roche | Interleukin-2 fusion proteins and their applications |
| TWI831347B (zh) | 2014-08-08 | 2024-02-01 | 日商中外製藥股份有限公司 | 包含４環性化合物的非晶質體之固體分散體及製劑 |
| EP3226843B1 (en) | 2014-12-05 | 2021-05-26 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| MA41107A (fr) | 2014-12-05 | 2017-10-10 | Aragon Pharmaceuticals Inc | Compositions anti-cancéreuses |
| AU2015358493B2 (en) | 2014-12-05 | 2021-05-06 | Aragon Pharmaceuticals, Inc. | Anticancer compositions |
| MA45090A (fr) * | 2016-06-03 | 2021-04-28 | Aragon Pharmaceuticals Inc | Compositions anticancéreuses |
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